MDR Conformity

Assessment Routes

By Royal Charter
MDR Conformity Assessment Routes 2

Contents
3 17
Class Is/Im/Ir devices Class III implantable devices

5 19
Class IIa devices Custom-made Class III implantable devices

8 21
Class IIb Annex VIII Rule 12 devices Custom-made devices
(Excluding custom-made Class III implantable
10 devices)

Class IIb implantable WET

22
Class IIb non-implantable non Rule 12 non WET
Class I devices
13 (Excluding Class Is, Ir, Im devices)

Class IIb implantable devices 23

(Excluding WET)
How BSI supports your Medical Devices launch
15
24
Class III non-implantable devices
CE-Excellence

DISCLAIMER:

Information presented in the conformity assessment flow charts and tables below is based on our current
understanding of the MDR requirements at the time of publishing this document; subject to change. The tables
do not cover assessments under the conformity routes Annex X (Type Examination) and Annex XI, Part B
(Product Verification) which may require additional tests or examinations of the devices. The tables present a
generalization of the requirements based on the classification of devices and some exceptions may apply.
MDR Conformity Assessment Routes 3 MDR Conformity Assessment Routes 4

Class Is/Im/Ir devices Applicable audits, assessments and requirements

Class Is/Im/Ir devices

Initial Surveillance
Class Is/Im/Ir Conformity
devices Assessment Y1 Y2 Y3 Y4 Y5

Class Annex II and III

Technical
QMS Audits Yes Yes Yes Recert** Yes Yes

Is, Im, Ir** Documentation

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Technical Documentation
N/A N/A N/A N/A N/A N/A
Assessment

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)
Annex XI* – Part A
Annex IX* QMS Summary of Safety and Clinical
Production Quality N/A N/A N/A N/A N/A N/A
Chapters I, III Performance (Article 32)
Assurance

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Report updates
plan

Updated as per manufacturer’s PMS, PMCF plans.

Post Market Clinical Follow-Up Update Report Notified Body QMS audits to verify implementation
(Article 61) of the plan by sampling complaints, vigilance
information etc.
Declaration of conformity
Post Market Surveillance (PMS) Report Updated when necessary and made available to
(Annex IV) (Article 80) the Notified Body upon request

Periodic Safety Update Report (Article 86) N/A N/A N/A N/A N/A

Unannounced Audits At least once every 5 years

CE marking
** C
 lass Ir (Class I re-usable
surgical instruments) (Annex V)
* L
 imited to sterility, metrology CE 2797
or re-use aspects as applicable

* If sterile or re-usable surgical instruments

** Q
 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 5 MDR Conformity Assessment Routes 6

Class IIa devices Applicable audits, assessments and requirements

Class IIa non-implantable devices

Initial Surveillance
Class IIa Conformity
non-implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Class IIa Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Technical Documentation Sample per

As per the Technical Documentation Sampling Plan
Assessment category of devices

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
Annex XI – Part A N/A N/A N/A N/A N/A N/A
Annex IX QMS Annex XI – Part B (Rule 14, Rule 18, Rule 21)
Production Quality
Chapters I, III Production Verification
Assurance Summary of Safety and Clinical
N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Updated as per manufacturer’s clinical evaluation

Annex IX Chapter II Annex II and Annex III Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Technical Documentation Technical Documentation Documentation Sampling Plan
Assessed per device catagory Assessed per device catagory
Updated as per manufacturer’s PMS, PMCF
Post Market Clinical Follow-Up Update Report
plans. Notified Body to review as per Technical
(Article 61)
Documentation Sampling Plan

PSUR update required at least once every 2

Declaration of conformity Periodic Safety Update Report (Article 86) years. Notified Body to review as per Technical
(Annex IV) Documentation Sampling Plan

Unannounced Audits At least once every 5 years

Continues on page 7

CE marking
(Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 7

Applicable audits, assessments and requirements

Class IIa implantable devices

Initial Surveillance
Class IIa Conformity
implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Technical Documentation Sample per

As per the Technical Documentation Sampling Plan
Assessment category of devices

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Updated at least annually “if indicated”. Notified

Summary of Safety and Clinical
Yes Body to review as per Technical Documentation
Performance (Article 32)
Sampling Plan or at the time of PSUR assessments

Updated as per manufacturer’s clinical evaluation

plan. Notified Body to review updates as per
Clinical Evaluation Report updates
Technical Documentation Sampling Plan or at the
time of PSUR assessments

Updated at least annually. Notified Body to review

Post Market Clinical Follow-Up Update Report
as per Technical Documentation Sampling Plan or at
(Article 61)
the time of PSUR assessments

Updated when necessary and at least every two

Periodic Safety Update Report (Article 86) years. submitted to Notified Body via EUDAMED for
Notified Body review

Unannounced Audits At least once every 5 years

* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 8 MDR Conformity Assessment Routes 9

Class IIb Annex VIII Rule 12 devices Applicable audits, assessments and requirements
Class IIb Annex VIII Rule 12 devices

Annex VIII Rule 12 devices – All active devices intended to administer and/or remove medicinal products,
body liquids or other substances to or from the body.

Class IIb Initial Surveillance

Annex VIII Rule Class IIb Conformity
Annex VIII Rule 12 devices Assessment Y1 Y2 Y3 Y4 Y5
12 devices
QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX QMS Annex X Technical Documentation Sample per

As per the Technical Documentation Sampling Plan
Assessment generic device group
Chapters I, III Type Examination
Yes, but exemptions
Clinical Evaluation Consultation May be required if any modifications to the device
may apply as per
Procedure (Article 54) adversely affect the risk-benefit ratio
Article 54.2

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)
Annex IX Chapter II Annex XI – Part A
Annex XI – Part B Summary of Safety and Clinical
Technical Documentation Production Quality N/A N/A N/A N/A N/A N/A
Production Verification Performance (Article 32)
Assessed per generic device group Assurance

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Clinical Evaluation Report updates plan. Notified Body to review updates as per
Consultation Procedure Technical Documentation Sampling Plan
Annex IX Sec 5 / Annex X Sec 6
Updated as per manufacturer’s PMCF plan
Post Market Clinical Follow-Up Update Report
Notified Body to review updates as per Technical
(Article 61)
Documentation Sampling Plan
Declaration of conformity
Updated at least annually. Notified Body to review
(Annex IV) Periodic Safety Update Report
updates as per Technical Documentation Sampling
(Article 86)
Plan

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 10 MDR Conformity Assessment Routes 11

Class IIb implantable WET Applicable audits, assessments and requirements

Class IIb implantable wet
Class IIb non-implantable non Rule 12 non WET
Well-Established Technologies (WET) - sutures, staples, dental fillings and braces, tooth crowns, screws,
wedges, plates, wires, pins, clips & connectors as per Article 52 of MDR.

Initial Surveillance
Class IIb
Class IIb
Conformity
implantable WET devices Assessment Y1 Y2 Y3 Y4 Y5
implantable WET
QMS Audits Yes Yes Yes Recert** Yes Yes

Class IIb Microbiology Audits Yes* N/A N/A Yes* N/A N/A
non-implantable
non Rule 12 Technical Documentation Sample per
As per the Technical Documentation Sampling Plan
non WET Assessment generic device group

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)
Annex IX QMS Annex X
Chapters I, III Type Examination Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Updated at least annually “if indicated”. Notified

Summary of Safety and Clinical Body to review updates as per Technical
Yes
Performance (Article 32) Documentation Sampling Plan or at the time
of PSUR assessments

Annex IX Chapter II Annex XI – Part A

Technical Documentation
Assessed per generic device group
Annex XI – Part B
Production Quality
Production Verification Updated as per manufacturer’s clinical evaluation
Assurance
Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Documentation Sampling Plan

Updated at least annually. Notified Body to review

Post Market Clinical Follow-Up Update Report
updates as per Technical Documentation Sampling
Declaration of conformity (Article 61)
Plan or at the time of PSUR assessments
(Annex IV)
Updated at least annually. Submitted to Notified Body
Periodic Safety Update Report
via EUDAMED for Notified Body review (assuming
(Article 86)
WET devices are implantable devices)

Unannounced Audits At least once every 5 years

CE marking Continues on page 12

(Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 12

Applicable audits, assessments and requirements

Class IIb non-implantable non WET non Rule 12 devices

Class IIb Initial Surveillance

non-implantable non-WET Conformity
non-Rule 12 devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Technical Documentation Sample per

As per the Technical Documentation Sampling Plan
Assessment generic device group

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)

Summary of Safety and Clinical

N/A N/A N/A N/A N/A N/A
Performance (Article 32)

Updated as per manufacturer’s clinical evaluation

Clinical Evaluation Report updates plan. Notified Body to review as per Technical
Documentation Sampling Plan

Updated as per manufacturer’s PMCF plan.

Post Market Clinical Follow-Up Update Report
Notified Body to review updates as per Technical
(Article 61)
Documentation Sampling Plan

Updated at least annually. Notified Body to review

Periodic Safety Update Report
updates as per Technical Documentation Sampling
(Article 86)
Plan

Unannounced Audits At least once every 5 years

* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 13 MDR Conformity Assessment Routes 14

Class IIb implantable devices Applicable audits, assessments and requirements

Class IIb implantable non-WET devices
Excluding WET
Class IIb Initial Surveillance
implantable non-WET Conformity
devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Class IIb Microbiology Audits Yes* N/A N/A Yes* N/A N/A

implantable devices Technical Documentation Review for every

N/A N/A N/A N/A N/A
non-WET Assessment device

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
Annex IX QMS Annex X N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)
Chapters I, III Type Examination
Updated at least annually “if indicated”. Notified Body
Summary of Safety and Clinical
Yes to review at the time of PSUR reviews or substantial
Performance (Article 32)
change reviews

Annex IX Chapter II Annex XI – Part A Updated as per manufacturer’s clinical evaluation

Annex XI – Part B Clinical Evaluation
Technical Documentation Production Quality Report updates
plan. Notified Body to review at the time of PSUR
Production Verification reviews or substantial change reviews
for every device Assurance
Updated at least annually. Notified Body to review
Post Market Clinical Follow-Up Update Report
at the time of PSUR reviews or substantial change
(Article 61)
reviews

Declaration of conformity Periodic Safety Update Report Updated at least annually. Submitted to Notified Body
(Annex IV) (Article 86) via EUDAMED for Notified Body review

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 15 MDR Conformity Assessment Routes 16

Class III non-implantable devices Applicable audits, assessments and requirements

Class III non-implantable devices

Including devices with medicinal substances, human tissue or animal tissue derivatives with TSE risk,
Class III Rule 21 devices.

Class III Initial Surveillance

non-implantable Class III Conformity
devices non-implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX QMS Annex X Technical Documentation Review for every

Chapters I, III Type Examination N/A N/A N/A N/A N/A
Assessment device

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Modifications to the devices may need

Consultations supplementary consultations; determined on a case-
If applicable
Annex IX Chapter II Annex XI – Part A (Rule 14, Rule 18, Rule 21) by-case basis taking into account the nature of the
Annex XI – Part B changes proposed
Technical Documentation Production Quality
Production Verification
for every device Assurance Updated at least annually “if indicated”. Notified Body
Summary of Safety and Clinical
Yes to review at the time of PSUR reviews or substantial
Performance (Article 32)
change reviews

Consultation
2001/83/EC, EC/726/2004, 2004/23/EC,
Updated as per manufacturer’s clinical evaluation
EU/722/2012 Clinical Evaluation Report updates plan. Notified Body to review at the time of PSUR
reviews or substantial change reviews

Updated at least annually. Notified Body to review

Declaration of conformity Post Market Clinical Follow-Up Update Report
at the time of PSUR reviews or substantial change
(Article 61)
(Annex IV) reviews

Periodic Safety Update Report Updated at least annually. Submitted to Noitified Body
(Article 86) via EUDAMED for Notified Body review

Unannounced Audits At least once every 5 years

CE marking
(Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 17 MDR Conformity Assessment Routes 18

Class III implantable devices Applicable audits, assessments and requirements

Class III implantable devices

Including devices with medicinal substances, human tissue or animal tissue derivatives with TSE risk,
Class III Rule 21 devices.

Class III Class III Initial Surveillance

Conformity
implantable devices implantable devices Assessment Y1 Y2 Y3 Y4 Y5

QMS Audits Yes Yes Yes Recert** Yes Yes

Microbiology Audits Yes* N/A N/A Yes* N/A N/A

Annex IX QMS Annex X Technical Documentation Review for every

N/A N/A N/A N/A N/A
Chapters I, III Type Examination Assessment device

Yes, but exemptions

Clinical Evaluation Consultation May be required if any modifications to the device
may apply as per
Procedure (Article 54) adversely affect the risk-benefit ratio
Article 54.2

Modifications to the devices may need

Consultations supplementary consultations; determined on a
Annex IX Chapter II Annex XI – Part A If applicable
Annex XI – Part B (Rule 14, Rule 18, Rule 21) case-by-case basis taking into account the nature
Technical Documentation Production Quality of the changes proposed
Production Verification
for every device Assurance
Updated at least annually ‘if indicated’. Notified
Summary of Safety and Clinical
Yes Body to review at the time of PSUR assessments or
Performance (Article 32)
substantial change reviews

Consultation
2001/83/EC, EC/726/2004, 2004/23/EC,
EU/722/2012 Updated as per manufacturer’s clinical evaluation
Clinical Evaluation Report updates plan. Notified Body to review at the time of PSUR
reviews or substantial change reviews

Clinical Evaluation Consultation

*Consultation Updated at least annually. Notified Body review at
Post Market Clinical Follow-Up Update Report
Procedure 2004/23/EC,
2001/83/EC, EC/726/2004, (Article 61)
the time of PSUR reviews or substantial change
Annex IX Sec 5 / Annex X Sec 6
EU/722/2012 reviews

Periodic Safety Update Report Updated at least annually. Submitted to Notified Body
(Article 86) via EUDAMED for Notified Body review

Unannounced Audits At least once every 5 years

Declaration of conformity
CE marking
(Annex IV) (Annex V)
CE 2797
* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 19 MDR Conformity Assessment Routes 20

Custom-made Class III implantable devices Applicable audits, assessments and requirements
Custom-made Class III implantable devices

Custom-made Initial Surveillance

Class III Conformity
implantable devices Assessment Y1 Y2 Y3 Y4 Y5

Custom-made Annex XIII

QMS Audits Yes Yes Yes Recert** Yes Yes

Class III Documentation Microbiology Audits Yes* N/A N/A Yes* N/A N/A

implantable Technical Documentation

N/A N/A N/A N/A N/A N/A
devices Assessment

Clinical Evaluation Consultation

N/A N/A N/A N/A N/A N/A
Procedure (Article 54)

Consultations
N/A N/A N/A N/A N/A N/A
(Rule 14, Rule 18, Rule 21)
Annex XI – Part A
Annex IX QMS
Production Quality Summary of Safety and Clinical
Chapters I Performance (Article 32)
N/A N/A N/A N/A N/A N/A
Assurance

Clinical Evaluation Report updates N/A N/A N/A N/A N/A

As per manufacturer’s PMS, PMCF plans. Notified

Post Market Clinical Follow-Up Update Report
Body QMS audits to verify implementation of
(Article 61)
the plan

Statement Updated at least annually. Not required to be

Periodic Safety Update Report submitted to EUDAMED for Notified Body review.
Annex XIII Section 1 (Article 86) Notified Body to verify updates at the time of
surveillance QMS audits

Unannounced Audits At least once every 5 years

CE Certificate
issued
CE 2797

* If sterile

 MS certificates are valid for three years, whilst CE certificates remain valid for a maximum of five years. The Y3 Recertification indicated in the
** Q
table relates to the EN ISO 13485:2016 certificate cycle. Certification cycles vary and re-certification may not always occur at Y3
MDR Conformity Assessment Routes 21 MDR Conformity Assessment Routes 22

Custom-made devices Class I devices

Excluding custom-made Class III implantable devices Excluding Class Is, Ir, Im devices

Custom-made Class I

Annex XIII Annex II and III

Documentation Technical
Documentation

Collect PMS, PMCF

Declaration of conformity
data as per Part B of
(Annex IV)
Annex XIV

CE marking
Statement
Annex XIII Section 1 (Annex V)

Note: No Notified Body involvement except for custom-made Class III implantable devices Note: No Notified Body involvement
MDR Conformity Assessment Routes
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Readiness
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MDR Conformity Assessment Routes 24
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For more information on our CE-Excellence services
call BSI on +44 345 080 9000 or visit our CE marking webpage
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